SUPPLY CHAIN ARTICLES

• The RNA Therapeutics Supply Chain: A Platform of Relationships

  Conversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.

• Can America's Retreat On mRNA Be Europe's Opportunity?

  With HHS winding down mRNA vaccine development under BARDA, could Europe seize the opportunity to lead in mRNA innovation? Exploring the policy shift's implications.

• The Price Is… Almost Right: mRNA Edition! COGS Reduction Strategies

  The following article will outline the current state of COGS in the mRNA industry and the work he and his colleagues undertook to more effectively utilize raw materials. But heaven forbid this be your normal conference panel write-up. No, below I share Parrella’s insights, but in the form of a never-before released episode of The Price is Right…or perhaps more fittingly given the state of the industry today, this spectacle is more aptly titled: The Price is…Sort Of, Almost, Not Quite Right! 

• FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities

  The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

• What Violin Making Can Teach Us About mRNA Therapeutic Quality

  Managing the mRNA supply chain and working in mRNA process development may not look anything like the work a luthier does to hew an instrument from an ancient spruce tree. But violin craftmanship actually serves as a fantastic metaphor for the challenging work the mRNA therapeutics space is tackling in sourcing and qualifying raw materials and optimizing the critical IVT reaction.

• Moderna & The Global mRNA Supply Chain: Regulatory Lessons Learned

  One of the most important reminders I took away from Moderna’s experiences ushering its mRNA vaccine onto the global market is that a commercial manufacturing process must also be accompanied by a commercially ready supply chain. Though sufficient physical volumes of each raw material and a redundant supplier network are necessities, physical scale is not the only “CQA” for which we must account when commercializing our supply chain.